GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk... | NCT07221214

Studies
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV

NCT07221214

Sponsor

Vanderbilt University Medical Center

Status

Recruiting

Last Update Posted

May 26, 2026Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

HIV
Alcohol
Smoking Cigarette
Cardiovascular Disease Prevention

Interventions

Semaglutide (Rybelsus®)
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1P60AA032176	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2026Actual

Primary Completion Date

Oct 31, 2029Estimated

Completion Date

Jan 31, 2030Estimated

First Submitted Date

Oct 23, 2025

First Submission Date that Met QC Criteria

Oct 23, 2025

First Posted Date

Oct 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2026

Last Update Posted Date

May 26, 2026Actual

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH
Norton Healthcare	OTHER
University of Louisville	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to learn if the drug semaglutide works to reduce alcohol intake among adults living with HIV. The main questions it aims to answer are:

Does semaglutide lower the average number of alcoholic beverages participants drink per week?
Does semaglutide lower the average number of cigarettes participants smoke per day?
Does semaglutide decrease the risk for cardiovascular disease among people living with HIV who drink alcohol and/or smoke tobacco?

Researchers will compare the effects of semaglutide to a placebo (a look-alike substance that contains no drug) to see if semaglutide works to lower the alcohol intake among participants each week.

Participants will:

Take semaglutide for 3 months
Visit the research clinic 3 times for checkups and tests
Provide blood samples, stool samples, and saliva samples for tests.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semaglutide	Experimental	drug intervention	Drug: Semaglutide (Rybelsus®)
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide (Rybelsus®)	Drug	experimental study medication	Semaglutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average drinks/week past 30 days at 3 months	Average drinks/week past 30 days (via Timeline Follow Back (TLFB))	3 Months

Secondary Outcomes

Measure	Description	Time Frame
Average cigarettes per day (cpd) past 30 days at 3 months	Average cigarettes per day in the past 30 days (via TLFB)	3 Months
Systemic inflammation (IL-6) at 3 months	Biomarker of systemic inflammation, Biomarker of gut permeability, Reynolds Risk Score, Mortality risk

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18-89
Prior diagnosis of HIV-1
Affiliated with Vanderbilt Comprehensive Care Clinic
On current ART regimen for at least 90 days prior to study entry with no missed doses for at least 7 consecutive days.
Most recent absolute CD4 count ≥ 300 cells/mm3 and drawn within 12 months of study enrollment
BMI ≥ 23 (calculated at screening)
Self-report of consuming alcohol in past 90 days
AUDIT-C ≥ 3 (male)/ ≥ 2 (female)
Has an established stable address at which they can receive mail and can be reached for the next 6 months
Willing and able to complete study procedures and follow-ups

Exclusion Criteria:

Known allergy to semaglutide
Currently taking GLP-1 RA (in the past 3 months)
History of diabetes defined by diagnosis in Problems List in medical record
History of pancreatitis
History of gastroparesis
Gallbladder disease (in the past 3 months)
History of medullary thyroid carcinoma
Family history of medullary thyroid carcinoma
History of multiple endocrine neoplasia syndrome type 2
Family history of multiple endocrine neoplasia syndrome type 2
Cognitive inability to consent
Barrier to speaking, hearing, reading, or writing English
Pregnant or breastfeeding, or planning to become pregnant in the next 6 months
Too ill to complete study procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hilary A Tindle, MD, MPH	Contact	615-875-9726		hilary.tindle@vumc.org
Rachel Jones, MS	Contact	615-421-3508		rachel.l.jones3@vumc.org

Overall Officials

Name	Affiliation	Role
Hilary A Tindle, MD, MPH	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center	Recruiting	Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000073865	Cigarette Smoking
D012907	Smoking
D002318	Cardiovascular Diseases

ID	Term
D000073869	Tobacco Smoking
D001519	Behavior
D064424	Tobacco Use